Kheiron
The KHEIRON Spinal Fixation System is a pedicle-screw construct for immobilizing and stabilizing thoracic, lumbar and sacral spinal segments as an adjunct to fusion. It combines screws and…
The KHEIRON Spinal Fixation System is a pedicle-screw construct for immobilizing and stabilizing thoracic, lumbar and sacral spinal segments as an adjunct to fusion. It combines screws and connecting components that can be assembled in different configurations.
The filing specifies compatibility with 5.5 mm and 6 mm rods and identifies the system material as Ti-6Al-4V ELI titanium alloy. Its intended use includes skeletally mature patients with spinal instability or deformity, as described in the FDA indications.
Listed Item
Large, closed derotation offset connector
Fixation Construct
The filing describes screws and connectors in varied sizes and shapes. It identifies posterior thoracolumbosacral fixation and adjunctive fusion as the system’s role and names Ti-6Al-4V ELI as its alloy.
15manufacturers in China registered for this device type
334catalogue numbers in this listing
10510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | S.m.a.i.o, France |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K201659 |
| Record published | 2020-12-14 |
| Record revised | 2026-03-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date, serial number |
| Sizes | Length 7.5 to 505 mm; outer diameter 4.5 to 8.5 mm; length 25 µm |
| Distribution end date | 2026-03-02 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 24BR55085 | Length 85 mm | In distribution |
| 24PW55050 | Length 50 mm | In distribution |
| 24PW75040 | Length 40 mm | In distribution |
| 24PW75085 | In distribution | |
| 27PC54130 | Length 13 mm | In distribution |
| 25SW65065 | Length 65 mm | In distribution |
| 24SR55075 | Outer Diameter 5.5 mm | In distribution |
| 24PW65035 | Length 35 mm | In distribution |
| 24SR55065 | Outer Diameter 5.5 mm | In distribution |
| 24PW95070 | In distribution | |
| 24PW95030 | In distribution | |
| 24PW75095 | In distribution | |
| 28IW85065 | In distribution | |
| 27AC51000 | In distribution | |
| 24SR60185 | Length 185 mm | In distribution |
| 28IW15055 | In distribution | |
| 27PC53130 | Length 13 mm | In distribution |
| 27PC53095 | Length 9.5 mm | In distribution |
| 27PC55150 | Length 15 mm | In distribution |
| 27PC53170 | Length 17 mm | In distribution |
| 24PW85060 | Length 60 mm | In distribution |
| 25SW65105 | In distribution | |
| 26PH67130 | In distribution | |
| 24PW65055 | Length 55 mm | In distribution |
| 25SW75100 | In distribution | |
| 24PW95060 | In distribution | |
| 26TC10100 | In distribution | |
| 28IW75075 | In distribution | |
| 24SR60035 | Length 35 mm | In distribution |
| 24PW55025 | Length 25 mm | In distribution |
| 24PW75030 | Length 30 mm | In distribution |
| 24SR55285 | Outer Diameter 5.5 mm | In distribution |
| 24PW85075 | In distribution | |
| 24CR55445 | In distribution | |
| 27PC55130 | Length 13 mm | In distribution |
| 24PW65025 | Length 25 mm | In distribution |
| 24SR60055 | Length 55 mm | In distribution |
| 25SW75045 | Length 45 mm | In distribution |
| 24SR60095 | In distribution | |
| 25SC60023 | In distribution | |
| 24PW65080 | In distribution | |
| 25SW75060 | Length 60 mm | In distribution |
| 24PW95055 | In distribution | |
| 24SR60085 | Length 45 mm | In distribution |
| 24PW45025 | Length 25 mm | In distribution |
| 28IW95080 | In distribution | |
| 24PW95080 | In distribution | |
| 24PW85070 | In distribution | |
| 24PW75035 | Length 35 mm | In distribution |
| 24SR55105 | Outer Diameter 5.5 mm | In distribution |
| 24BR55055 | Length 55 mm | In distribution |
| 24BR60075 | Length 75 mm | In distribution |
| 27PC54170 | Length 17 mm | In distribution |
| 28IW95065 | In distribution | |
| 24PW65110 | In distribution | |
| 27PC52110 | Length 11 mm | In distribution |
| 25SW65095 | In distribution | |
| 24SR55185 | Outer Diameter 5.5 mm | In distribution |
| 25SW65090 | In distribution | |
| 24BR60045 | Length 45 mm | In distribution |
| 24SR55135 | Outer Diameter 5.5 mm | In distribution |
| 25SW75035 | Length 35 mm | In distribution |
| 24PW85085 | In distribution | |
| 24PW95100 | In distribution | |
| 24PW45040 | Length 40 mm | In distribution |
| 28IW65070 | In distribution | |
| 24PW95050 | In distribution | |
| 27PC54150 | Length 15 mm | In distribution |
| 24PW85095 | In distribution | |
| 24BR60055 | Length 55 mm | In distribution |
| 25SP55921 | In distribution | |
| 25SW65030 | Length 30 mm | In distribution |
| 30KR55004 | In distribution | |
| 24PW95110 | In distribution | |
| 30KR60003 | In distribution | |
| 26SL00050 | In distribution | |
| 25SP55922 | In distribution | |
| 27PC54075 | Length 7.5 mm | In distribution |
| 24PW56635 | Length 70 mm | In distribution |
| 28IW85080 | In distribution | |
| 27PC53150 | Length 15 mm | In distribution |
| 30KR55003 | In distribution | |
| 24BR55035 | Length 35 mm | In distribution |
| 24BR55045 | Length 45 mm | In distribution |
| 28IW75055 | In distribution | |
| 25SW75065 | Length 65 mm | In distribution |
| 24PW85025 | Length 25 µm | In distribution |
| 25SW65110 | In distribution | |
| 28IW65065 | In distribution | |
| 30KR60001 | In distribution | |
| 25SW65070 | Outer Diameter 6.5 mm | In distribution |
| 24SR55095 | Outer Diameter 5.5 mm | In distribution |
| 25SW75110 | In distribution | |
| 28IW75060 | In distribution | |
| 24SR55115 | Outer Diameter 5.5 mm | In distribution |
| 25SW65040 | Length 40 mm | In distribution |
| 26PH67100 | In distribution | |
| 28IW95060 | In distribution | |
| 28IW85075 | In distribution | |
| 24PW75080 | In distribution | |
| 26TC10050 | In distribution | |
| 24BR55065 | Length 65 mm | In distribution |
| 28IW85090 | In distribution | |
| 26TC20100 | In distribution | |
| 25SW65085 | In distribution | |
| 25SW65045 | Length 45 mm | In distribution |
| 24PW55700 | In distribution | |
| 24BR60105 | Length 105 mm | In distribution |
| 26SL00075 | In distribution | |
| 24SR60135 | Length 135 mm | In distribution |
| 28IW75080 | In distribution | |
| 28IW65075 | In distribution | |
| 24PW56625 | Length 70 mm | In distribution |
| 25SP55622 | In distribution | |
| 24PW95065 | In distribution | |
| 25SW75090 | In distribution | |
| 28IW15070 | In distribution | |
| 25SW65035 | Length 35 mm | In distribution |
| 29TC60001 | In distribution | |
| 24PW75090 | In distribution | |
| 28IW75065 | In distribution | |
| 24BR55075 | Length 75 mm | In distribution |
| 24PW65070 | In distribution | |
| 28IW15075 | In distribution | |
| 24PW85030 | Length 30 mm | In distribution |
| 24PW75050 | Length 50 mm | In distribution |
| 27PC55001 | In distribution | |
| 25SW75085 | In distribution | |
| 25SW75055 | Length 55 mm | In distribution |
| 24PW56630 | Length 70 mm | In distribution |
| 27PC52150 | Length 15 mm | In distribution |
| 24PW85050 | Length 50 mm | In distribution |
| 24BR60095 | Length 95 mm | In distribution |
| 24PW55030 | Length 30 mm | In distribution |
| 24PW55055 | Length 55 mm | In distribution |
| 27PC52075 | Length 7.5 mm | In distribution |
| 28IW95090 | In distribution | |
| 25SW65080 | In distribution | |
| 24PW75105 | In distribution | |
| 26TC00001 | In distribution | |
| 24PW85110 | In distribution | |
| 27PC52095 | Length 9.5 mm | In distribution |
| 24PW45060 | Length 60 mm | In distribution |
| 28IW15100 | In distribution | |
| 25SP55621 | In distribution | |
| 25SW75030 | Length 30 mm | In distribution |
| 26SP45100 | In distribution | |
| 27PC52130 | Length 13 mm | In distribution |
| 24PW65105 | In distribution | |
| 24SR60505 | Length 505 mm | In distribution |
| 24SR60115 | Length 115 mm | In distribution |
| 27PC55170 | Length 17 mm | In distribution |
| 24SR55035 | Length 35 mm | In distribution |
| 26PH00001 | In distribution | |
| 24SR55045 | Outer Diameter 5.5 mm | In distribution |
| 24CR55945 | In distribution | |
| 25SW65100 | In distribution | |
| 24PW65090 | In distribution | |
| 24PW85090 | In distribution | |
| 28IW65110 | In distribution | |
| 24BR60115 | Length 115 mm | In distribution |
| 24PW45030 | Length 30 mm | In distribution |
| 28IE56025 | In distribution | |
| 30KR55001 | In distribution | |
| 24CR55645 | In distribution | |
| 29TC55002 | In distribution | |
| 28IW15080 | In distribution | |
| 28IW85100 | In distribution | |
| 28IE56030 | In distribution | |
| 24PW85040 | Length 40 mm | In distribution |
| 28IE56020 | In distribution | |
| 24PW95040 | In distribution | |
| 24PW65095 | In distribution | |
| 27PC53075 | Length 7.5 mm | In distribution |
| 24PW75110 | In distribution | |
| 24SR55055 | Outer Diameter 5.5 mm | In distribution |
| 25SW75050 | Length 50 mm | In distribution |
| 24PW85105 | In distribution | |
| 26SP67100 | In distribution | |
| 24PW65030 | Length 30 mm | In distribution |
| 24SR55085 | Outer Diameter 5.5 mm | In distribution |
| 28IW85055 | In distribution | |
| 24PW95045 | In distribution | |
| 28IW75110 | In distribution | |
| 24PW75060 | Length 60 mm | In distribution |
| 26TC10075 | In distribution | |
| 24PW85045 | Length 45 mm | In distribution |
| 24PW55035 | Length 35 mm | In distribution |
| 24PW75055 | Length 55 mm | In distribution |
| 24PW95075 | In distribution | |
| 30KR60004 | In distribution | |
| 24SR55505 | Outer Diameter 5.5 mm | In distribution |
| 26PH45130 | In distribution | |
| 28IW15065 | In distribution | |
| 28IW95100 | In distribution | |
| 25SN55006 | In distribution | |
| 24CR60445 | In distribution | |
| 24PW95085 | In distribution | |
| 28IW95075 | In distribution | |
| 28IW85110 | In distribution | |
| 28IW95055 | In distribution | |
| 25SW65055 | Length 55 mm | In distribution |
| 27PC55110 | Length 11 mm | In distribution |
| 24PW65050 | Length 50 mm | In distribution |
| 25SW75105 | In distribution | |
| 24PW65060 | Length 60 mm | In distribution |
| 26SL00100 | In distribution | |
| 24PW85035 | Length 35 mm | In distribution |
| 24PW95105 | In distribution | |
| 24PW55045 | Length 45 mm | In distribution |
| 24BR55105 | Length 105 mm | In distribution |
| 24PW95090 | In distribution | |
| 26SP45130 | In distribution | |
| 25SW75070 | Length 70 mm | In distribution |
| 24PW95095 | In distribution | |
| 24PW55060 | Length 60 mm | In distribution |
| 24PW95025 | In distribution | |
| 24SR60045 | Length 45 mm | In distribution |
| 24PW56620 | Length 70 mm | In distribution |
| 24CR60645 | In distribution | |
| 30KR55000 | Outer Diameter 5.5 mm | In distribution |
| 28IW75090 | In distribution | |
| 28IW15110 | In distribution | |
| 24PW75025 | Length 25 mm | In distribution |
| 25SW75075 | In distribution | |
| 24PW60600 | In distribution | |
| 28IW85060 | In distribution | |
| 24SR60285 | Length 285 mm | In distribution |
| 25SW75095 | In distribution | |
| 28IW65100 | In distribution | |
| 24PW75070 | In distribution | |
| 24BR55115 | Length 115 mm | In distribution |
| 24PW75045 | Length 45 mm | In distribution |
| 30KR60000 | Outer Diameter 6 mm | In distribution |
| 26TC20075 | In distribution | |
| 24PW65085 | In distribution | |
| 28IW15090 | In distribution | |
| 29TC60002 | In distribution | |
| 27PC53110 | Length 11 mm | In distribution |
| 24PW45050 | Length 50 mm | In distribution |
| 28IW65090 | In distribution | |
| 24CR60945 | In distribution | |
| 24SR60075 | Length 75 mm | In distribution |
| 24PW75065 | In distribution | |
| 28IW75100 | In distribution | |
| 26SP67130 | In distribution | |
| 27PC54110 | Length 11 mm | In distribution |
| 24PW85065 | In distribution | |
| 28IW65060 | In distribution | |
| 28IW65055 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K262828 | 2026-09-04 |
| K253802 | 2026-07-01 |
| K260786 | 2026-04-03 |
| K253990 | 2026-01-07 |
| K253721 | 2025-12-17 |
| K251804 | 2025-07-08 |
| K232650 | 2023-09-29 |
| K211981 | 2022-06-09 |
| K211414 | 2021-08-10 |
| K201659 | 2020-10-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.